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FDA 510(k)

DYNATRON THERMOSTIM PROBE-DONE

K-Number: K120835 · 2012-08-20

ApplicantDynatronics Corporation
Decision Date2012-08-20
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DYNATRON THERMOSTIM PROBE-DONE is the device name listed in this FDA 510(k) record. The listed applicant is Dynatronics Corporation. It received FDA 510(k) clearance on 2012-08-20 under 510(k) number K120835. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNATRON THERMOSTIM PROBE-DONE?

DYNATRON THERMOSTIM PROBE-DONE is a medical device that received FDA 510(k) clearance on 2012-08-20. The listed applicant is Dynatronics Corporation. The 510(k) number is K120835.

When did DYNATRON THERMOSTIM PROBE-DONE receive FDA 510(k) clearance?

DYNATRON THERMOSTIM PROBE-DONE received FDA 510(k) clearance on 2012-08-20, under 510(k) number K120835.

Who is the listed applicant for DYNATRON THERMOSTIM PROBE-DONE?

The FDA 510(k) record lists Dynatronics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNATRON THERMOSTIM PROBE-DONE?

The FDA product code for DYNATRON THERMOSTIM PROBE-DONE is GXY.

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Official Source

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